ACRP Exam QUESTIONS AND
ANSWERS GRADED A LAEST 2023/2024
What individual serves as the primary liaison between the
sponsor and the investigator? - CORRECT ANSWER monitor
Who is responsible for verifying that the investigator follows the
approved protocol and all approved amendments? - CORRECT
ANSWER monitor
Who must be notified if a trial is suspended or terminated
prematurely? - CORRECT ANSWER the sponsor should
promptly inform the investigator/institutions and the regulatory
authorities of the termination or suspension and the reasons for
the termination or suspension
Who must the monitor inform of CRF entry errors, omissions, or
illegibly? - CORRECT ANSWER investigator
factoral design - CORRECT ANSWER Used for the specific
purpose of examining interaction of A and B; 2 or more treatments
are evaluated simultaneously through the use of varying
combinations of the treatments
1. A alone
2. B alone
3. both A & B (useful in determining joint effects of A & B)
4. neither A or B
*another important use of the design is to establish the dose-
response characteristics of the simultaneous use of treatments C
&D
,What are the purposes of multi center trials? - CORRECT
ANSWER 1. an accepted way of evaluating a new medication
more efficiently; may present as the only practical means of
accruing sufficient subjects to satisfy the trial objective within a
reasonable time-frame
2. to provide a better bias for the subsequent generalization of its
findings
phase I (human pharmacology) - CORRECT ANSWER
SAFETY; starts with the initial administration of an investigational
new drug into humans; small # of study subjects 20-80
aspects of phase 1 trials
- to determine the tolerability of the dose range expected to be
needed for later clinical studies and to determine the nature of
adverse reactions that can be expected
- characterization of a drug's absorption, distribution, metabolism,
and excretion continues throughout the development plan
-pharmacodynamic studies and studies relating drug blood levels
to response (PK/PD studies) may be conducted healthy volunteer
subjects or in patients with the target disease
phase II (therapeutic exploratory) - CORRECT ANSWER
EFFICACY; the primary objective is to explore therapeutic
efficacy in patients; studies are typically conducted in a group of
patients who are selected by relatively narrow criteria, leading to a
relatively homogenous population and are closely monitored;
early studies often utilize dose escalation designs; several 100
subjects
goal
- determine the dose(s) and regimen for phase III trials
- include evaluation of potential study endpoints, therapeutic
regimens, and target populations
, - determine short term side effects and risks associated with the
drug
phase III (therapeutic confirmatory) - CORRECT ANSWER
LONG-TERM SAFETY/SURVIVAL; primary objective is to
demonstrate, or confirm therapeutic benefit; designed to confirm
the preliminary evidence accumulated in phase II that a drug is
safe and effective for use in the intended indication and recipient
population; they complete the information needed to support
adequate instructions for use of the drug (official product
information); several 100 - 1000's of subjects
studies may further explore the dose-response relationship, or
explore the drug's use in wider populations, in different stages of
disease, or in combination with another drug
*end of phase III is when NDA is sent to the FDA for approval
phase IV (therapeutic use) - CORRECT ANSWER POST
MARKET; begins after drug approval; are all studies (other than
routine surveillance) performed after drug approval and related to
the approved indication; address FDA requirements for additional
information not in NDA
commonly conducted studies include additional drug-drug
interaction, dose-response or safety studies, and studies
designed to support use under the approved indication, e.g.
mortality/morbidity studies, epidemiological studies
adverse event - CORRECT ANSWER any untoward medical
occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not
necessarily have to have a causal relationship with this treatment
e.g. abnormal laboratory finding, symptom, or disease
ANSWERS GRADED A LAEST 2023/2024
What individual serves as the primary liaison between the
sponsor and the investigator? - CORRECT ANSWER monitor
Who is responsible for verifying that the investigator follows the
approved protocol and all approved amendments? - CORRECT
ANSWER monitor
Who must be notified if a trial is suspended or terminated
prematurely? - CORRECT ANSWER the sponsor should
promptly inform the investigator/institutions and the regulatory
authorities of the termination or suspension and the reasons for
the termination or suspension
Who must the monitor inform of CRF entry errors, omissions, or
illegibly? - CORRECT ANSWER investigator
factoral design - CORRECT ANSWER Used for the specific
purpose of examining interaction of A and B; 2 or more treatments
are evaluated simultaneously through the use of varying
combinations of the treatments
1. A alone
2. B alone
3. both A & B (useful in determining joint effects of A & B)
4. neither A or B
*another important use of the design is to establish the dose-
response characteristics of the simultaneous use of treatments C
&D
,What are the purposes of multi center trials? - CORRECT
ANSWER 1. an accepted way of evaluating a new medication
more efficiently; may present as the only practical means of
accruing sufficient subjects to satisfy the trial objective within a
reasonable time-frame
2. to provide a better bias for the subsequent generalization of its
findings
phase I (human pharmacology) - CORRECT ANSWER
SAFETY; starts with the initial administration of an investigational
new drug into humans; small # of study subjects 20-80
aspects of phase 1 trials
- to determine the tolerability of the dose range expected to be
needed for later clinical studies and to determine the nature of
adverse reactions that can be expected
- characterization of a drug's absorption, distribution, metabolism,
and excretion continues throughout the development plan
-pharmacodynamic studies and studies relating drug blood levels
to response (PK/PD studies) may be conducted healthy volunteer
subjects or in patients with the target disease
phase II (therapeutic exploratory) - CORRECT ANSWER
EFFICACY; the primary objective is to explore therapeutic
efficacy in patients; studies are typically conducted in a group of
patients who are selected by relatively narrow criteria, leading to a
relatively homogenous population and are closely monitored;
early studies often utilize dose escalation designs; several 100
subjects
goal
- determine the dose(s) and regimen for phase III trials
- include evaluation of potential study endpoints, therapeutic
regimens, and target populations
, - determine short term side effects and risks associated with the
drug
phase III (therapeutic confirmatory) - CORRECT ANSWER
LONG-TERM SAFETY/SURVIVAL; primary objective is to
demonstrate, or confirm therapeutic benefit; designed to confirm
the preliminary evidence accumulated in phase II that a drug is
safe and effective for use in the intended indication and recipient
population; they complete the information needed to support
adequate instructions for use of the drug (official product
information); several 100 - 1000's of subjects
studies may further explore the dose-response relationship, or
explore the drug's use in wider populations, in different stages of
disease, or in combination with another drug
*end of phase III is when NDA is sent to the FDA for approval
phase IV (therapeutic use) - CORRECT ANSWER POST
MARKET; begins after drug approval; are all studies (other than
routine surveillance) performed after drug approval and related to
the approved indication; address FDA requirements for additional
information not in NDA
commonly conducted studies include additional drug-drug
interaction, dose-response or safety studies, and studies
designed to support use under the approved indication, e.g.
mortality/morbidity studies, epidemiological studies
adverse event - CORRECT ANSWER any untoward medical
occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not
necessarily have to have a causal relationship with this treatment
e.g. abnormal laboratory finding, symptom, or disease
